Efficacy and Safety Study of Adipiplon, Placebo and an Active Control in Primary Insomniacs

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be a multi-center, randomized, blinded, comparative, placebo-controlled, 4 arm crossover study in patients with primary insomnia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurogen Corporation
• Treatments: Adipiplon; Zolpidem

Criteria

Inclusion Criteria:

• Be between the ages of 21 and 64 years, inclusive;

• Have a body mass index (BMI) between 21 and 34 kg/m2, inclusive;

• Be a primary insomniac as defined by DSM-IV criteria; in particular difficulty with both sleep initiation and sleep maintenance;

• Have subjective Latency to Sleep Onset > 45 minutes;

• Have a mean habitual subjective TST of <6.5 hours;

• Have a TST of 240 - 420 minutes at each of two baseline PSGs;

• Have a mean LPS > 20min, with neither value <15 minutes and mean WASO > 40 minutes on baseline PSGs;

• Be in good general health as determined by a thorough medical history and physical examination (including vital signs), 12-lead ECG and clinical laboratory tests;

• Have clinical laboratory values within normal reference range or not clinically significantly abnormal as judged by the Principal Investigator;

• Be off any investigational drug for at least 30 days prior to screening;

• If the patient is a female of childbearing potential, she must be using an acceptable method of contraception, must have a negative serum pregnancy test at screening, and must have a negative urine pregnancy test before randomization.

• Female patients who have been surgically sterilized or have had a hysterectomy are eligible if they have a negative pregnancy test at screening;

• Be able to read, understand, and provide written/dated informed consent before enrolling in the study, and must be willing to comply with all study procedures.

Exclusion Criteria:

• Clinically significant unstable medical illness;

• Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease;

• History of cancer other than basal cell carcinoma, squamous cell carcinoma of the skin or cancer in situ within 5 years of screening;

• Supine or sitting blood pressure > 140/90 mmHg at the screening or baseline visits;

• Heart rate >100 bpm at the screening or baseline visits;

• Within the past three years, clinically significant psychiatric illness, including chronic psychiatric illness or any Axis I condition;

• History or presence of chronic pain;

• History of epilepsy or serious head injury;

• Other than primary insomnia, a history of clinically significant sleep disorder including narcolepsy, parasomnia as an adult, circadian rhythm disorder, restless leg syndrome, or on the initial baseline PSG, sleep apnea [Apnea Hypopnea Index (AHI) >10] or Periodic Limb Movement Disorder [Periodic Limb Movement Arousal Index (PLMAI) > 10];

• Any condition that may affect drug absorption;

• Smokers who habitually smoke more than 10 cigarettes per day or smoke during the overnight hours;

• Travel across more than three time zones, an expected change in sleep schedules of 3 hours or more, or involvement in rotating shift work within 14 days prior to screening or during the study period;

• Self-report of napping ≥30 minutes more than 2 times per week within the last month;

• Any clinically significant abnormal finding on physical examination, vital signs, ECG, or clinical laboratory tests, as determined by the investigator. (The QTc interval must be ≤430 msec. for males and ≤450 msec for females);

• Known or suspected diagnosis of Acquired Immune Deficiency Syndrome, or previous or current positive result on human immunodeficiency virus antibody or antigen testing;

• History or laboratory finding of positive hepatitis B surface antigen or hepatitis C core antibody;

• History of allergies, or known sensitivity, hypersensitivity, or adverse reaction to any drug similar to adipiplon, including benzodiazepines, or zolpidem, zaleplon, zopiclone, or eszopiclone;

• Use of any psychotropic medications, including over-the-counter (OTC) and herbal products, that may affect sleep/wake function within one week or five half-lives (whichever is longer) prior to screening or need to use any of these medications at any time during the study;

• Pregnant or lactating females;

• Positive serum pregnancy test at screening or urine pregnancy test at baseline;

• Recent history (≤ one year) of alcohol or drug abuse, or current evidence of substance dependence or abuse as defined by DSM-IV criteria;

• Regular consumption of large amounts of xanthine-containing substances (i.e. more than 5 cups of coffee or equivalent amounts of xanthine-containing substances per day);

• Have eaten grapefruit or had grapefruit juice from baseline through the completion of study dosing;

• Self report of a usual consumption of more than 14 units of alcohol per week;

• Requiring the concomitant usage of any 3A4 inhibitors;

• Any prior exposure to adipiplon (formerly known as NG2-73).